A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Tricuspid Valve Clipping Systems in Patients With Severe or Greater Tricuspid Regurgitation.
A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Tricuspid Valve Clipping Systems in Patients With Severe or Greater Tricuspid Regurgitation.
The transcatheter tricuspid valve clipping system is specially designed for the treatment of tricuspid regurgitation. Under the guidance of ultrasound and DSA imaging, the investigational device is advanced into the right ventricle via a femoral or jugular venous puncture approach. The clipping component grasps the edges of the dysfunctional valve leaflets (usually unable to close properly), thereby reducing the area of the tricuspid orifice that fails to coapt normally, achieving minimally invasive treatment of tricuspid regurgitation.
Inclusion Criteria:
Age ≥ 18 years, male or female;
Patients with severe or greater tricuspid regurgitation (TR ≥ 4+) judged by the local study team to have received adequate treatment according to applicable standards and remained stable for at least 30 days (TR grading to be determined by the core laboratory);
Adequate treatment is defined as:
Oral diuretic therapy for tricuspid regurgitation at a stable dose for at least 30 days; Guideline-directed medical therapy for heart failure (if applicable) according to heart failure subtype with different ejection fractions, at a stable dose for at least 30 days; For subjects with mitral regurgitation (MR ≥ 3+), atrial fibrillation, or coronary artery disease: medical therapy for ≥ 30 days, or ≥ 30 days post device-based therapy with stable clinical status.
Stable dose is defined as: dose increase ≤ 100% or dose reduction ≤ 50%.
The multidisciplinary heart team (comprising cardiologists, cardiovascular surgeons, imaging specialists, anesthesiologists, etc., with at least 2 physicians) judges that the subject is at moderate or high surgical risk (Tri-Score ≥ 4.0) and is expected to benefit from tricuspid edge-to-edge repair;
Left ventricular ejection fraction (LVEF) ≥ 20%;
Presence of symptoms attributable to tricuspid regurgitation (e.g., chest distress, dyspnea, shortness of breath, lower extremity edema, ascites), or asymptomatic subjects with right ventricular dilation or impaired right ventricular function (as determined by the core laboratory);
Impaired right ventricular function is defined as: tricuspid annular plane systolic excursion (TAPSE) < 17 mm or fractional area change (FAC) < 35%.
NYHA functional class II to IV, inclusive;
Subject voluntarily agrees to participate in the clinical trial and provides written informed consent, or consent is provided by the subject's legal representative.
Exclusion Criteria:
Patients with pulmonary artery systolic pressure ≥ 60 mmHg: if right heart catheterization was performed, results shall be based on right heart catheterization; if not performed, results shall be based on echocardiography (assessed by the core laboratory).
Tricuspid valve anatomy that, in the judgment of the core laboratory, may preclude implantation, proper positioning of the tricuspid clip device, fail to sufficiently reduce TR severity, or achieve adequate leaflet apposition, including but not limited to:
Severe calcification in the leaflet grasping zone; Severe leaflet perforation, cleft, or other lesions that impede device implantation; Ebstein's anomaly; TR expected to be unamenable to reduction to grade 2+ or lower post-procedure with edge-to-edge repair.
Presence of a prosthetic valve or annuloplasty ring at the tricuspid valve position, or prior tricuspid valve surgery that, in the judgment of the core laboratory, would interfere with study device implantation or therapeutic effect.
Tricuspid stenosis, defined as tricuspid valve area ≤ 1.0 cm² and/or mean tricuspid gradient > 5 mmHg (assessed by the core laboratory).
Tricuspid valve anatomy that cannot be evaluated by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
Evidence of mass, thrombus, or vegetation in the cardiac chambers, access-related veins (jugular or femoral vein, depending on the selected access route for the individual subject), superior vena cava, or inferior vena cava (depending on the selected access route for the individual subject).
Patients in whom bilateral femoral veins are unsuitable for 23 Fr sheath access due to disease or anatomy, and bilateral jugular veins are unsuitable for 21 Fr sheath access (i.e., both transfemoral and transjugular access are contraindicated).
Severe uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg).
Prior implantation of a pacemaker (excluding leadless pacemakers) or implantable cardioverter-defibrillator (ICD), or planned implantation of a pacemaker (excluding leadless pacemakers) or ICD that, in the judgment of the core laboratory, would interfere with study device implantation or therapeutic effect, or where study device implantation would interfere with the pacemaker or ICD.
Hemodynamic instability, defined as systolic blood pressure < 90 mmHg, cardiogenic shock, requirement for inotropic support, intra-aortic balloon pump, or other hemodynamic support devices.
End-stage refractory heart failure requiring specialized interventions (e.g., mechanical circulatory support, heart transplantation, etc.).
Patients with more than moderate aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation; or patients scheduled for cardiac surgery within the next 12 months.
Percutaneous coronary intervention within the previous 1 month.
Myocardial infarction within the previous 1 month or known unstable angina.
Cerebrovascular accident within the previous 3 months.
Patients with active infective endocarditis or active rheumatic heart disease.
Patients with coagulopathy, hypercoagulable state, or anemia (hemoglobin < 90 g/L).
Patients with acute infection or other severe infection.
Patients with active peptic ulcer or active gastrointestinal bleeding.
Transient ischemic attack (TIA) within 30 days, or prior stroke with permanent disability (mRS > 4).
Severe end-stage disease (e.g., malignant tumor, severe pulmonary disease, hepatic disease, renal failure) with life expectancy < 1 year.
Patients with known hypersensitivity or contraindications to the study device materials or study medications (e.g., antiplatelet agents, anticoagulants).
Alcohol, drug, or substance addiction.
Patients with cognitive impairment.
History of primary or persistent epilepsy poorly controlled by medication, or psychiatric disorders.
Participation in any other clinical trial (except registry studies) within 30 days prior to signing the informed consent form.
Chronic dialysis patients.
Females who are pregnant, breastfeeding, or planning to become pregnant during the clinical trial.
Any other conditions deemed inappropriate by the investigator for participation in this clinical trial.
tina.chen@hh-healthcare.com+86-15986752781
021-60046990